Multi-centre Randomized Controlled Trial of angiotensin converting enzyme inhibitor (ACEi) /angiotensin receptor blocker (ARB) - withdrawal in chronic kidney disease – STOP-ACEi-STUDY (SAS)

血管紧张素转换酶抑制剂 (ACEi)/血管紧张素受体阻滞剂 (ARB) 的多中心随机对照试验 - 慢性肾脏病停药 — STOP-ACEi-STUDY (SAS)

• 批准号: MC_PC_14138
• 负责人: Sunil Bhandari
• 金额: $ 31.12万
• 依托单位: Hull & East Yorkshire Hosp (replace)
• 依托单位国家: 英国
• 项目类别: Intramural
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MC_PC_14138
• 关键词: Multi; centre; Randomized; Controlled; Trial

Chronic kidney disease (CKD) affects 1 in 10 adults in the UK and describes progressive loss of function of the kidneys over a period of months or years regardless of the original kidney disease. CKD can have serious implications for those affected including a risk of CKD progressing to complete kidney failure so that the affected person requires replacement of kidney function by dialysis treatment or kidney transplantation. Kidney disease is expensive with a high proportion of the health-care budget spent on people with CKD; the cost of dialysis treatment alone is ~£30,000/year. Patient quality of life can be poor, with dialysis leading to early death. Treating high blood pressure (BP) is the most important intervention that can slow progression of CKD to total kidney failure. Some people with CKD gain additional protection from drugs called Angiotensin Converting Enzyme inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs). These drugs treat high BP but also slow CKD progression by changing the pressure in the kidney. This may also influence hormone pathways that contribute to the decline of kidney function. However recent research suggests that in some people with advanced CKD (stages 4 & 5) who are progressing to complete kidney failure and are receiving treatment with an ACEi and/ or ARB, stopping these drugs leads to stabilization and improvement of kidney function and decreases or delays the need for dialysis treatment. This indicates that in some patients the very tablets that are being used to protect the kidneys may be contributing to a harmful decline in their function by some currently unknown mechanism. To date, the research on this is observational and to confirm the association between stopping these drugs and stabilization of kidney function requires a study to compare the outcomes of a group of people who have had these drugs stopped with a group who continue on the drug. This is called a randomised controlled trial (RCT). In the STOP-ACEi trial we will randomly allocate suitable participants (by chance) to either continue or to stop their ACEi/ARB treatment and then to follow-up these participants for 3-years. This study is needed before this treatment strategy can be put into routine clinical practice. In addition we will look at other effects of stopping these drugs such as effects on heart attacks, strokes and participant quality of life.

在英国，十分之一的成年人患有慢性肾病 (CKD)，并且无论最初的肾病如何，都会在数月或数年内逐渐丧失肾脏功能，这可能会对受影响的人产生严重影响，包括 CKD 的风险。进展为完全肾衰竭，以致受影响的人需要通过透析治疗或肾移植来替代肾功能。 肾脏疾病的费用很高，因为透析治疗的费用占医疗保健预算的很大一部分；仅每年约 30,000 英镑，患者的生活质量可能很差，治疗高血压 (BP) 是减缓 CKD 发展为完全肾衰竭的最重要的干预措施。获得血管紧张素转换酶抑制剂 (ACEi) 或血管紧张素受体阻滞剂 (ARB) 药物的额外保护，这些药物不仅可以治疗高血压，还可以通过改变血压来减缓 CKD 的进展。这也可能影响导致肾功能衰退的激素途径，但最近的研究表明，在一些患有晚期 CKD（第 4 期和第 5 期）的患者中，他们正在进展为完全肾衰竭并正在接受 ACEi 治疗。 /或ARB，停止这些药物可以稳定和改善肾功能，并减少或延迟透析治疗的需要。这表明，在某些患者中，用于保护肾脏的药片可能会导致肾功能的有害下降。他们的功能迄今为止，对此的研究是观察性的，为了确认停止使用这些药物与稳定肾功能之间的关系，需要进行一项研究来比较一组停止使用这些药物的人与另一组人的结果。这称为随机对照试验 (RCT) 在 STOP-ACEi 试验中，我们将随机分配合适的参与者继续或停止他们的 ACEi/ARB 治疗，然后进行随访。这些是为了这项研究需要三年时间才能将这种治疗策略投入常规临床实践。此外，我们还将研究停止这些药物对参与者的其他影响，例如对心脏病发作、中风和生活质量的影响。

项目成果

How Do We Navigate the Complexities Surrounding the Use of Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers in Chronic Kidney Disease?

我们如何应对在慢性肾脏病中使用血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂的复杂性？

• DOI: http://dx.10.1016/j.mayocp.2019.09.014
• 发表时间: 2019
• 期刊: Mayo Clinic proceedings
• 影响因子: 8.9
• 作者: Bhandari S

In reply: Is diabetes still a compelling indication for renin-angiotensin-aldosterone system inhibitors?

回复：糖尿病仍然是肾素-血管紧张素-醛固酮系统抑制剂的一个令人信服的适应症吗？

• DOI: http://dx.10.3949/ccjm.87c.01002
• 发表时间: 2020
• 期刊: Cleveland Clinic journal of medicine
• 影响因子: 6.1
• 作者: Bhandari S

Multicentre randomized controlled trial of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker withdrawal in advanced renal disease: the STOP-ACEi trial.

晚期肾病中血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂停药的多中心随机对照试验：STOP-ACEi 试验。

• DOI: http://dx.10.1093/ndt/gfv346
• 发表时间: 2016
• 期刊: official publication of the European Dialysis and Transplant Association - European Renal Association
• 作者: Bhandari S

ACE inhibitors and ARBs: Managing potassium and renal function.

ACE 抑制剂和 ARB：管理钾和肾功能。

• DOI: http://dx.10.3949/ccjm.86a.18024
• 发表时间: 2019
• 期刊: Cleveland Clinic journal of medicine
• 影响因子: 6.1
• 作者: Momoniat T

Renin-Angiotensin System Inhibition in Advanced Chronic Kidney Disease.

晚期慢性肾脏病中的肾素-血管紧张素系统抑制。

• DOI: http://dx.10.1056/nejmoa2210639
• 发表时间: 2022
• 期刊: The New England journal of medicine
• 作者: Bhandari S